Last week, I attended a webinar that showcased the results of a study on the adoption of clinical trial software in life sciences. The study was conducted by a working group led by the Tufts Center for the Study of Drug Development, CDISC, and Oracle Health Sciences, and the results reiterated what we already […]
Posts Tagged ‘clinical data management system’
Twitter Highlights: Post-Production Changes To #OC/RDC Studies
Last week, Tammy Dutkin, our director of clinical data management and EDC, presented a webinar in which she discussed best practices for making post-production changes to Oracle Clinical and Remote Data Capture (RDC). If you missed it, you can watch the recording here.
Does 21 CFR Part 11 Apply To CTMS, CDMS, Or EMR/EHR Systems?
On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: Does 21 CFR 11 apply to a CTMS (clinical trial management system), CDMS (clinical data management system), EMR (electronic medical record), or […]
No Surprise: #1 CRO Uses Oracle’s Clinical Trial Software
What do you do when the largest contract research organization (CRO) in the world agrees to appear in a video promoting several products? You watch, of course! Quintiles recently recorded a video that features the company’s president of clinical development discussing their use of Oracle Health Sciences solutions, such as Siebel Clinical Trial Management […]
The Trifecta Of Validation
Validation. Admit it – you cringed a little. It’s almost like a dirty word in our industry. That thing that slows down system implementations. That thing that adds a bunch of time and cost to IT projects. That annoying, but necessary, evil. Well, okay, it’s not really “evil,” per say. It is, after all, designed […]
Cloud Fact Or Fiction: Can You Always Access Your Clinical and Safety Data In The Cloud?
Last time, we concluded that the costs associated with hosting clinical trial software in the cloud can actually be less than for on-site solutions. In this post, we’ll tackle access to data and system uptime. Claim #4: Clinical or safety data stored in the cloud can be accessed at any time. Fact or fiction? Fact. […]
Cloud Fact Or Fiction: Are Ongoing Costs Associated with Hosting Clinical Trial Software High?
In our last “cloud fact or fiction” post, we discussed the cost of implementing clinical trial software in the cloud. This time around we’ll address the ongoing costs you can expect to see if you decide that hosting your applications in the cloud is the way to go. Claim #3: Ongoing costs for cloud/hosted clinical […]
Oracle Clinical/RDC/TMS 5.1 Released
Oracle recently announced a new version of Oracle Clinical, Remote Data Capture (RDC), and Thesaurus Management System (TMS). Some of the enhancements in version 5.1 include: Support for Partial Source Data Verification (SDV): Oracle Clinical and RDC Onsite now support creating a risk-based SDV plan that identifies only a subset of data requiring verification in […]
Cloud Fact Or Fiction: Can Clinical Trial Software Be Implemented Faster In The Cloud?
Anyone evaluating clinical trial, clinical data, and safety management systems today will also need to decide whether to implement on-site or in the cloud. As each year passes, more and more companies are choosing the cloud for a whole host (pun intended!) of reasons. Over the next few weeks, my colleagues and I will examine […]
Navigating The Road To Creating Custom Roles in OC/RDC
On November 13, 2014, I’ll be delivering Taking Ownership of Custom Database Roles in Oracle Clinical and RDC, a one-hour webinar that’ll cover the following topics: Reasons to create custom roles Process of creating a custom role Granting the necessary access and privileges to a new role Granting the new role to the appropriate user […]
Managing a CDMS is Hard Enough, Let Alone Complex Data Migrations
Senior Management is always looking for answers about what works, what doesn’t, and how best to design and manage clinical trials. In order to get those answers, all of your trial data needs to be in one place and in a consistent format – this is the only way to extract accurate information. But, how […]
Parke-Davis Seems Like Yesterday
In a few days, Perficient will be attending the 19th Oracle Health Sciences User Group (OHSUG) annual meeting in St. Louis. I have been privileged to attend all previous user group meetings, beginning with the very first one back in 1996 in Ann Arbor, Michigan. Approximately 100 people gathered in a conference room at Parke-Davis […]